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FDA impressed by AI-powered blood test | Comparing TAVR valves | A big approval for GE HealthCare | New HCM drug delivers

News You Need to Know Today
FDA impressed by AI-powered blood test | Comparing TAVR valves | A big approval for GE HealthCare | New HCM drug delivers
Wednesday, May 14, 2025
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Today's News and Trends

FDA gives AI-powered blood test for obstructive CAD breakthrough device designation

The FDA clearly sees significant potential in a new multi-protein blood test from Prevencio. The company's goal is to gain full approval and get the test in the hands of emergency departments all over the United States.

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blood test research laboratory
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FDA gives AI-powered blood test for obstructive CAD breakthrough device designation

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blood test research laboratory
The FDA clearly sees significant potential in a new multi-protein blood test from Prevencio. The company's goal is to gain full approval and get the test in the hands of emergency departments all over the United States.
READ MORE >

Cardiologist highlights safety, effectiveness of Boston Scientific TAVR valve

Andreas Ruck, MD, discussed new registry data on Boston Scientific’s Acurate neo2 TAVR valve, comparing it to popular devices from Edwards Lifesciences and Medtronic.

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Video interview with Andreas Ruck, MD, explaining a SWEDHEART registry comparison of Acurate Neo2 to Sapien and Evolut TAVR valves.
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Cardiologist highlights safety, effectiveness of Boston Scientific TAVR valve

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Video interview with Andreas Ruck, MD, explaining a SWEDHEART registry comparison of Acurate Neo2 to Sapien and Evolut TAVR valves.
Andreas Ruck, MD, discussed new registry data on Boston Scientific’s Acurate neo2 TAVR valve, comparing it to popular devices from Edwards Lifesciences and Medtronic.
READ MORE >

FDA approves popular ultrasound enhancing agent for pediatric patients

Unlike other UEA options, GE HealthCare's Optison does not contain polyethylene glycol. The FDA approved its use for adult patients back in 1997.

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GE HealthCare Optison ultrasound enhancing agent used to enhance otherwise suboptimal echocardiograms and better show the borders of the chambers of the heart.
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FDA approves popular ultrasound enhancing agent for pediatric patients

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GE HealthCare Optison ultrasound enhancing agent used to enhance otherwise suboptimal echocardiograms and better show the borders of the chambers of the heart.
Unlike other UEA options, GE HealthCare's Optison does not contain polyethylene glycol. The FDA approved its use for adult patients back in 1997.
READ MORE >

New drug for obstructive HCM outperforms the current standard of care

Cytokinetics announced positive results from a new clinical trial comparing aficamten monotherapy to the beta blocker metoprolol.

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Many attendees shot selfies in front of the the massive heart on display in the Cytokinetic booth at AHA 2022.
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New drug for obstructive HCM outperforms the current standard of care

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Many attendees shot selfies in front of the the massive heart on display in the Cytokinetic booth at AHA 2022.
Cytokinetics announced positive results from a new clinical trial comparing aficamten monotherapy to the beta blocker metoprolol.
READ MORE >

Featured Articles

When valves fail: Surgeons share advice for treating high-risk patients with TAVR explant and SAVR

When a patient’s TAVR valve fails, redo TAVR is not always a feasible option. TAVR explantation and SAVR are typically the answer in these cases, but that approach is associated with certain risks. 

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According to the U.S. government, Asante Health System and one of its surgeons knowingly submitted false claims to Medicare, Medicaid and TRICARE for more than six years. Heart surgery surgeons.
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When valves fail: Surgeons share advice for treating high-risk patients with TAVR explant and SAVR

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According to the U.S. government, Asante Health System and one of its surgeons knowingly submitted false claims to Medicare, Medicaid and TRICARE for more than six years. Heart surgery surgeons.
When a patient’s TAVR valve fails, redo TAVR is not always a feasible option. TAVR explantation and SAVR are typically the answer in these cases, but that approach is associated with certain risks. 
READ MORE >

GE HealthCare debuts new wide-bore MRI scanner built with cardiology, oncology in mind

The new 1.5T MRI scanner includes a wide bore and key AI features designed to boost the patient experience.

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GE HealthCare SIGNA Sprint MRI
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GE HealthCare debuts new wide-bore MRI scanner built with cardiology, oncology in mind

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GE HealthCare SIGNA Sprint MRI
The new 1.5T MRI scanner includes a wide bore and key AI features designed to boost the patient experience.
READ MORE >

ASNC, ACC ask US government not to tariff radiopharmaceuticals

The two groups stressed that tariffs would likely impact patient care.

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Cardiac SPECT nuclear imaging myocardial perfusion_Spectrum Dynamics_RSNA22_DF_3.jpeg
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ASNC, ACC ask US government not to tariff radiopharmaceuticals

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Cardiac SPECT nuclear imaging myocardial perfusion_Spectrum Dynamics_RSNA22_DF_3.jpeg
The two groups stressed that tariffs would likely impact patient care.
READ MORE >

Gastric bypass surgery linked to lower heart attack risk than gastric sleeve

Both operations can help obese patients lose weight, researchers noted, but gastric bypass surgery "may be associated with greater cardiovascular benefits."

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stomach surgery gastric bypass gastric sleeve heart risks
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Gastric bypass surgery linked to lower heart attack risk than gastric sleeve

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stomach surgery gastric bypass gastric sleeve heart risks
Both operations can help obese patients lose weight, researchers noted, but gastric bypass surgery "may be associated with greater cardiovascular benefits."
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In Case You Missed It

Society of Thoracic Surgeons shares new risk calculator for complex aortic procedures

The new resource was built to help care teams plan for ascending aorta and aortic root surgeries.

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Society of Thoracic Surgeons shares new risk calculator for aortic surgeries
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Society of Thoracic Surgeons shares new risk calculator for complex aortic procedures

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Society of Thoracic Surgeons shares new risk calculator for aortic surgeries
The new resource was built to help care teams plan for ascending aorta and aortic root surgeries.
READ MORE >

PFA takes center stage at Heart Rhythm 2025 as medtech companies share new data

Pulsed field ablation was one of the biggest topics at Heart Rhythm 2025, the annual meeting of the Heart Rhythm Society. Medtronic, Johnson & Johnson MedTech, Boston Scientific, Abbott, Kardium and Field Medical all shared new data at the conference highlighting the safety and effectiveness of their advanced PFA technologies. 

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Heart Rhythm 2025 Heart Rhythm Society President Kenneth A. Ellenbogen, MD
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PFA takes center stage at Heart Rhythm 2025 as medtech companies share new data

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Heart Rhythm 2025 Heart Rhythm Society President Kenneth A. Ellenbogen, MD
Pulsed field ablation was one of the biggest topics at Heart Rhythm 2025, the annual meeting of the Heart Rhythm Society. Medtronic, Johnson & Johnson MedTech, Boston Scientific, Abbott, Kardium and Field Medical all shared new data at the conference highlighting the safety and effectiveness of their advanced PFA technologies. 
READ MORE >

Medtronic receives FDA approval for smallest defibrillation lead of its kind

Medtronic emphasized that this device should be especially valuable when treating younger patients or those with a small anatomy.

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OmniaSecure defibrillation lead for placement within a patient’s right ventricle
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Medtronic receives FDA approval for smallest defibrillation lead of its kind

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OmniaSecure defibrillation lead for placement within a patient’s right ventricle
Medtronic emphasized that this device should be especially valuable when treating younger patients or those with a small anatomy.
READ MORE >

In Other News

Healthcare AI newswatch: FDA’s ‘rush’ to the AI altar, AI and Medicare Advantage, OpenAI benchmarks healthcare AI

For some, the FDA is moving too fast in its drive to adopt generative AI agency-wide. 

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FDA artificial intelligence AI aggressive
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Healthcare AI newswatch: FDA’s ‘rush’ to the AI altar, AI and Medicare Advantage, OpenAI benchmarks healthcare AI

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FDA artificial intelligence AI aggressive
For some, the FDA is moving too fast in its drive to adopt generative AI agency-wide. 
READ MORE >

Research links tissue patterns on imaging with breast cancer risk

These findings could be beneficial for women with dense breasts, which increase the risk of developing cancer while making it significantly more difficult to detect. 

READ MORE >
Experts use radiomics features to spot specific tissue patterns related to breast cancer.
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Research links tissue patterns on imaging with breast cancer risk

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Experts use radiomics features to spot specific tissue patterns related to breast cancer.
These findings could be beneficial for women with dense breasts, which increase the risk of developing cancer while making it significantly more difficult to detect. 
READ MORE >

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